Medical Editor: John P. Cunha, DO, FACOEP
What Is Cinryze?
Cinryze (c1 esterase inhibitor [human]) Freeze Dried Powder is a man-made form of a protein that occurs naturally in the bloodstream and helps control inflammation in the body and is used in people with hereditary angioedema. The Berinert brand of this medication is used to treat attacks of angioedema. The Cinryze brand is used to prevent attacks of angioedema.
What Are Side Effects of Cinryze?
Common side effects of Cinryze include:
- stomach pain
- changes in sense of taste
- cold symptoms (stuffy nose, sneezing, sore throat), or
- mild itching or rash
Dosage for Cinryze
A dose of 1,000 Units Cinryze can be administered every 3 or 4 days for routine prophylaxis against angioedema attacks in HAE patients.
What Drugs, Substances, or Supplements Interact with Cinryze?
Cinryze may interact with other drugs. Tell your doctor all medications and supplements you use.
Cinryze During Pregnancy and Breastfeeding
During pregnancy, Cinryze should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Cinryze (c1 esterase inhibitor [human]) Freeze Dried Powder Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Get emergency medical help if you have signs of an allergic reaction: hives; chest tightness, fast heartbeats, feeling light-headed; wheezing or difficult breathing, blue lips or gums; or swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- sudden numbness or weakness on one side of the body;
- pain, swelling, warmth, or redness in an arm or leg;
- sudden severe headache, confusion, problems with vision, speech, or balance;
- chest pain while taking deep breaths; or
- fast heart rate.
Common side effects may include:
- unusual or unpleasant taste in your mouth;
- headache, dizziness;
- nausea, vomiting;
- pain, bruising, itching, swelling, bleeding, warmth, or a hard lump where the medicine was injected;
- stuffy nose, sore throat;
- rash; or
Read the entire detailed patient monograph for Cinryze (C1 Esterase Inhibitor [Human] Freeze Dried Powder)
The only serious adverse reaction observed in clinical studies of CINRYZE was cerebrovascular accident.
The most common adverse reactions observed were headache, nausea, rash, and vomiting.
Because CINRYZE is a therapeutic protein, there is potential for immunogenicity. Using a validated assay there was no evidence of antibody development following administration of CINRYZE. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of anti-C1 Esterase Inhibitor antibody positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibody development across products cannot be made.
Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Twenty-four subjects were evaluated in the randomized, placebo-controlled, crossover, routine prophylaxis trial.
There were no serious adverse reactions in the randomized, placebo-controlled, crossover, routine prophylaxis trial.
Adverse reactions in the randomized, placebo-controlled, crossover, routine prophylaxis trial (n=24) that occurred in at least two subjects (≥8%) receiving CINRYZE are given in the following table:
Table 2 Adverse Reactions in the Randomized, Placebo-Controlled, Cross over, Routine
|Adverse Reaction||Number of Adverse Reactions||Number
(N = 24)
In an open-label follow-on trial, 146 patients received a median of 243.5 days of CINRYZE (maximum = 959 days). The most common adverse reaction observed was headache. No patients were discontinued due to an adverse reaction.
Adverse reactions in the open-label follow-on trial (n=146) that occurred in at least three subjects (≥2%) receiving CINRYZE, are given in the following table:
Table 3 Adverse Reactions in the Open-Label Follow-On Trial
|Adverse Reaction||Number (%) of Subjects
(N=146) with Adverse Reaction
|Number (%) of Infusion Days
(N=11,435) with Adverse Reaction
|Headache||28 (19)||62 (0.5)|
|Nausea||26 (18)||29 (0.3)|
|Rash||15 (10)||30 (0.3)|
|Vomiting||15 (10)||17 (0.1)|
|Pyrexia||7 (5)||7 (<0.1)|
|Catheter Site Pain||4 (3)||5 (<0.1)|
|Dizziness||3 (2)||4 (<0.1)|
|Erythema||3 (2)||3 (<0.1)|
|Pruritus||3 (2)||4 (<0.1)|
More than 14,000 doses of CINRYZE have been administered to over 260 different patients in all completed, controlled and open-label clinical studies. All patients who were evaluated were found negative for seroconversion to parvovirus B19, Hepatitis B, Hepatitis C and HIV. (See Transmissible Infectious Agents)
Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions or establish a causal relationship to product exposure.
Postmarketing adverse reactions include local infusion site reactions (including inflammation or hematoma at the infusion site) and hypersensitivity.
Read the entire FDA prescribing information for Cinryze (C1 Esterase Inhibitor [Human] Freeze Dried Powder)